Endometriosis affects one in 10 women, but diagnosis of this fertility impairing, and often painful condition often takes a decade. A growing number of companies hope to put women with the condition on the path to treatment much sooner with new diagnostics and investors, investigators and regulators see bright opportunities in the field. Read More
Litigation over how to assign royalties for intellectual property with an offshore subsidiary doesn’t consume the kind of billable attorney hours that patent disputes do, but the question can affect a multinational corporation’s bottom line in significant ways. The U.S. Tax Court recently decided on a method for assigning royalties to a Medtronic plc subsidiary located in Puerto Rico that fell between the rate sought by Medtronic and the rate sought by an appeals court, but that ultimate rate was close to that preferred by Medtronic, handing the company a better outcome than it might have predicted when the IRS filed suit. Read More
Xeltis BV raised $15 million in series D2 funding to develop its restorative vascular access device for patients with chronic kidney disease who are on hemodialysis. The investment in this technology, called the Axess graft, came from Hong Kong-based China Grand Pharmaceutical and Healthcare Holdings Ltd. (Grand Pharma). The deal focuses mainly on commercializing Axess, but also involves other new products in the field of hemodialysis developed as part of the Xeltis technology platform. The commitment from Grand Pharma includes equity investment and product licensing, representing Xeltis’ first commercial deal and its first funding from an Asian concern. Read More
Integra Lifesciences Holdings Corp., of Plainsboro, N.J., said in its latest 8K filing that it has decided to voluntarily remove all the company’s Cerelink systems – which are indicated for intracranial pressure monitoring – due to customer reports that these monitors were returning inaccurate pressure readings. Read More
It’s that time of year when the U.S. Trade Representative asks for help as it prepares its list of notorious markets for counterfeiting and piracy. While it’s not exhaustive, the annual list is composed of online and physical markets around the world that deal in commercial-scale counterfeiting and piracy across all sectors, including biopharma and med tech. Read More
A dozen years after the Dodd-Frank Act was signed into U.S. law, the SEC adopted a final rule Aug. 25 implementing the law’s so-called “pay-vs.-performance” provisions related to executive compensation. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bristol Myers, Cardio Diagnostics, Fundamentalvr, Healpros, Intelligent Retinal Imaging, Medserv Plus, Pathai, Prestige Medical Imaging, Sonde Health, Teleflex, Todos Medical, X-Ray Visions, XRV. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ultrasight. Read More
